Treatment of large kidney cancer masses using internal radiation therapy
Prospective Study of Interstitial Brachytherapy for Unresectable/Unablatable T1b/T2a Renal Masses
This study is testing a new type of radiation therapy for patients with large kidney cancer that can't be removed or treated with other methods to see if it can help shrink the tumor and improve their outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04473781 on ClinicalTrials.gov |
What this trial studies
This phase I/II trial investigates the safety and effectiveness of interstitial brachytherapy for patients with unresectable or unablatable kidney cancer. The approach involves temporarily placing a radiation source near the tumor to target and potentially reduce its size, thereby limiting its growth. The study aims to evaluate local control of the tumor, treatment response, and progression-free survival over a 12-month period. Patients will receive 1-2 fractions of brachytherapy and will be monitored for side effects and tumor response over a follow-up period of at least three years.
Who should consider this trial
Good fit: Ideal candidates include patients with biopsy-proven renal cell carcinoma who are not suitable for surgery or ablative techniques and have tumors sized between 4 to 10 cm.
Not a fit: Patients with locally advanced or metastatic disease, or those whose tumors can be treated with surgery or ablative techniques, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-surgical option for patients with large kidney tumors, potentially reducing tumor size and the risk of cancer spread.
How similar studies have performed: Other studies have shown promise with brachytherapy for various cancers, suggesting potential success for this novel application in kidney cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elected to undergo interstitial brachytherapy as part of conventional treatment for renal cell carcinoma * Biopsy proven renal cell carcinoma * No definitive evidence of locally advanced (nodal or tumor thrombus) or distant (metastatic) disease * Lesion size (maximal dimension) of 4 to 10 cm * Patient not a candidate for curative surgery (unwilling or unable to pursue surgery) * Lesion cannot be reliably treated with ablative techniques * Entire lesion able to be treated adequately by brachytherapy per radiation oncologist * Tumor predominantly solid (\~ \> 80%) * Lesion that has been observed for \>= 6 months with demonstrable growth rate anticipated to be \>= 4 mm/year by same imaging modality * Renal tumor that is amenable to percutaneous access for interstitial renal brachytherapy (Institutional Review Board \[IRB\]) * Hemoglobin \> 9 * Absolute neutrophil count (ANC) \>= 1500/uL (microliter) * Platelets \>= 100,000/uL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 upper limit of normal (ULN) * Total bilirubin =\< ULN * A competent immune system * Estimated glomerular filtration rate (eGFR) \>= 30 * Good performance status (Eastern Cooperative Oncology Group \[ECOG\]) \< 2 * Understanding and willingness to provide consent * No prior systemic treatment for kidney cancer * Women of childbearing potential must have negative pregnancy test at start of therapy Exclusion Criteria: * Presence of an active, untreated, non-renal malignancy * Uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction within 6 months * History of bleeding diathesis or recent bleeding episode * Need for urgent treatment of renal cancer due bleeding, pain, or paraneoplastic syndrome * Prior surgery or radiation therapy to the operative site * Unwillingness to undergo clinical and laboratory monitoring and/or imaging studies
Where this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Albert J Chang — UCLA / Jonsson Comprehensive Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.